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Transvaginal Mesh Lawsuits Continue To Increase As Efficacy Of FDA 501 (k) Program Debated

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Johnson & Johnson’s Ethicon unit is facing over 100 lawsuits regarding its Gyncare Prolift  transvaginal mesh, used in the treatment of pelvic organ prolapse (POP). One of the more recent lawsuits was filed by Linda Gross of Watertown, S.D.

Gross had the mesh implanted in 2006 to remedy POP, and has since had 12 surgeries to remove the mesh and relieve her of the constant pain and swelling she is experiencing. Gross says she can’t have sex with her husband, can’t sit for over 20 minutes, and can only be active for a few minutes at a time. “It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Gross told “I wouldn’t wish this on anyone.”

The FDA approved Gyncare Prolift through the 501 (K) program, one that allows medical devices to be fast tracked through regulatory procedures if they are substantially equivalent to a device on the market. Currently, the FDA is considering pulling transvaginal mesh devices from the market. The FDA approved Gynecare Prolift in 2008, two years after Gross had the device implanted.

A preliminary review by the FDA has urged that the mesh be reclassified, and put through the standard safety regulations that it was able to bypass through the 501 (k) program. This move comes too late for the more than 75,000 women who have had the mesh implanted, and the 35 percent of them who are experiencing mesh erosion, infection, pain, and bleeding. disclaimer: This article: Transvaginal Mesh Lawsuits Continue To Increase As Efficacy Of FDA 501 (k) Program Debated was posted on Monday, September 12th, 2011 at 8:02 pm at and is filed under Medical Device Lawsuits.

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